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Sublingual Immunotherapy in Children With Allergic Rhinitis (SLIT)

Primary Purpose

Allergic Rhinitis

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Mite, Mite and Bacterial or Placebo

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring IgA antibody, IgE antibody, IgG1/IgG4 subclasses, Mite allergy, Sublingual immunotherapy, Saliva

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical diagnosis of allergic rhinitis
Positive skin test to Dermatophagoides pteronyssinus total extract
Positive serum levels of specific IgE to D. pteronyssinus extract

Exclusion Criteria:

Previous allergen immunotherapy
Use of antihistamines 1 week or topical corticosteroid up to 3 weeks prior to skin prick test
Long term use of systemic corticosteroid.
Airway infection 30 days prior to the selection.
Children with severe asthma, malignant, cardiovascular or autoimmune diseases, under chemotherapy or immunosuppressor therapy.
Users of cigarette smoke
Presence of severe skin lesions

Sites / Locations

Asthma and Rhinitis Control Program

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

mite allergen drop

mite plus bacterial extracts

Placebo

Arm Description

Children with allergic rhinitis sensitized with dust mites will receive progressive doses of allergen drops comparing those receiving placebo.

Vaccine constituted with mite and bacterial extracts will be compared to placebo.

Placebo will be constituted by the same solution used to make dilution of the allergen extracts.

Outcomes

Primary Outcome Measures

Change from Baseline in Symptom and Medication Scores at 12 months

For clinical evaluation will be used a questionnaire determining the symptom and medication scores.

Secondary Outcome Measures

Change from Baseline in Specific Antibody Levels.

Measurement of serum specific antibodies (IgE, IgG1, IgG4, and IgA) to Dermatophagoides pteronyssinus total extract, and Der p 1 and Der p 2 allergens.

Full Information

NCT ID

NCT01506843

First Posted

December 20, 2011

Last Updated

January 9, 2012

Sponsor

Federal University of Uberlandia

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

1. Study Identification

Unique Protocol Identification Number

NCT01506843

Brief Title

Sublingual Immunotherapy in Children With Allergic Rhinitis

Acronym

SLIT

Official Title

Clinical Efficacy and Mucosal/Systemic Antibody Response Changes After Sublingual Immunotherapy in Mite-allergic Children in a Randomized Double-blind, Placebo-controlled Study in Brazil

Study Type

Interventional

2. Study Status

Record Verification Date

August 2007

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of Uberlandia

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the clinical efficacy and mucosal/systemic antibody response changes after SLIT using house dust mite allergen with or without bacterial extracts in mite-allergic children.

Detailed Description

Patients with allergic rhinitis with or without asthma were selected for a randomized double-blind, placebo-controlled trial and distributed into three groups: DPT (Dpt allergen extract, n=34), DPT+MRB (Dpt allergen plus mixed respiratory bacterial extracts, n=36), and Placebo (n=32). Clinical evaluation and immunological analyses are being carried out before and after 12 and 18 months of treatment, including rhinitis/asthma symptom and medication scores, skin prick test (SPT) to Dpt, and measurements of Dpt-, Der p 1-, Der p 2-specific serum IgE, IgG4, IgG1 and -specific salivary IgA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis

Keywords

IgA antibody, IgE antibody, IgG1/IgG4 subclasses, Mite allergy, Sublingual immunotherapy, Saliva

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

mite allergen drop

Arm Type

Active Comparator

Arm Description

Children with allergic rhinitis sensitized with dust mites will receive progressive doses of allergen drops comparing those receiving placebo.

Arm Title

mite plus bacterial extracts

Arm Type

Active Comparator

Arm Description

Vaccine constituted with mite and bacterial extracts will be compared to placebo.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo will be constituted by the same solution used to make dilution of the allergen extracts.

Intervention Type

Biological

Intervention Name(s)

Mite, Mite and Bacterial or Placebo

Other Intervention Name(s)

mite allergen extract, bacterial allergen extract

Intervention Description

All treatments were given by sublingual route according to schedule of EAACI, with some modification. Patients received up-dosing sublingual drops once a day, reaching in approximately 3 months a monthly maintenance dose of 36 μg of Der p 1 given three times a week in alternate days for mite, mite and bacterial allergen extract, and no Der p 1 and no bacterial components in the placebo group. Doses were delivered by using vials equipped with a metered-dose dropper, and subjects were instructed to hold the solution under the tongue for 2 min and not to eat or drink for 60 min after the dose. Subjects self-administered the treatment at home. Adjustments in the schedule were made on an individual basis according to standard guidelines for specific immunotherapy

Primary Outcome Measure Information:

Title

Change from Baseline in Symptom and Medication Scores at 12 months

Description

For clinical evaluation will be used a questionnaire determining the symptom and medication scores.

Time Frame

Baseline and 12 months

Secondary Outcome Measure Information:

Title

Change from Baseline in Specific Antibody Levels.

Description

Measurement of serum specific antibodies (IgE, IgG1, IgG4, and IgA) to Dermatophagoides pteronyssinus total extract, and Der p 1 and Der p 2 allergens.

Time Frame

Baseline, 12 months and 18 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of allergic rhinitis Positive skin test to Dermatophagoides pteronyssinus total extract Positive serum levels of specific IgE to D. pteronyssinus extract Exclusion Criteria: Previous allergen immunotherapy Use of antihistamines 1 week or topical corticosteroid up to 3 weeks prior to skin prick test Long term use of systemic corticosteroid. Airway infection 30 days prior to the selection. Children with severe asthma, malignant, cardiovascular or autoimmune diseases, under chemotherapy or immunosuppressor therapy. Users of cigarette smoke Presence of severe skin lesions

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ernesto A Taketomi, MD, PhD

Organizational Affiliation

Federal University of Uberlandia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asthma and Rhinitis Control Program

City

Itumbiara

State/Province

Goias

ZIP/Postal Code

75503-520

Country

Brazil

12. IPD Sharing Statement

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Sublingual Immunotherapy in Children With Allergic Rhinitis

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